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Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

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ClinicalTrials.gov Identifier: NCT01085903
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Spatial Neglect
Dysphagia
Interventions Drug: Modafinil
Drug: Placebo
Behavioral: Baseline
Behavioral: CPS
Behavioral: Post CPS
Behavioral: Follow up
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Subjects Baseline Stroke Subjects: Placebo Then Modafinil Stroke Subjects: Modafinil Then Placebo
Hide Arm/Group Description

Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Period Title: Overall Study
Started 21 4 3
Completed 21 4 3
Not Completed 0 0 0
Arm/Group Title Normal Subjects Stroke Subjects Total
Hide Arm/Group Description

Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Total of all reporting groups
Overall Number of Baseline Participants 21 7 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 7 participants 28 participants
51.286  (21.462) 71.429  (9.914) 58.2  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 7 participants 28 participants
Female
8
  38.1%
3
  42.9%
11
  39.3%
Male
13
  61.9%
4
  57.1%
17
  60.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 7 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.8%
1
  14.3%
2
   7.1%
White
18
  85.7%
6
  85.7%
24
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   9.5%
0
   0.0%
2
   7.1%
1.Primary Outcome
Title P50 Percent Habituation Score
Hide Description This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).
Time Frame baseline and after three days of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Subjects: Baseline vs CPS Stroke Subjects: Baseline vs CPS Stroke Subjects: Modafinil Stroke Subjects: Placebo Stroke Subjects Placebo vs Modafinil
Hide Arm/Group Description:

Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Overall Number of Participants Analyzed 21 7 7 7 7
Mean (Standard Deviation)
Unit of Measure: percentage of change in amplitude
-44.12  (59.29) -45.84  (228.09) 113.63  (154.5) 61.41  (102.5) 52.223  (222.94)
2.Secondary Outcome
Title PVT Fastest 10 Percent of Reaction Times
Hide Description This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).
Time Frame baseline and after three days of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Subjects: Baseline vs CPS Stroke Subjects: Baseline vs CPS Stroke Subjects: Modafinil Stroke Subjects: Placebo Stroke Subjects Placebo vs Modafinil
Hide Arm/Group Description:

Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Overall Number of Participants Analyzed 21 7 7 7 7
Mean (Standard Deviation)
Unit of Measure: milliseconds
-10.57  (21.66) 20.57  (29.20) 244.71  (186.62) 235.64  (150.62) 9.07  (38.73)
3.Secondary Outcome
Title Power Function Exponent for Oral Bolus Estimation
Hide Description This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).
Time Frame baseline and after three days of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Subjects: Baseline vs CPS Stroke Subjects: Baseline vs CPS Stroke Subjects: Modafinil Stroke Subjects: Placebo Stroke Subjects Placebo vs Modafinil
Hide Arm/Group Description:

Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Overall Number of Participants Analyzed 21 7 7 7 7
Mean (Standard Deviation)
Unit of Measure: exponent
.014  (.113) -.004  (.196) .54  (.17) .49  (.19) .04  (.08)
4.Secondary Outcome
Title Time to Swallow Puree Food
Hide Description This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).
Time Frame baseline and after three days of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Subjects: Baseline vs CPS Stroke Subjects: Baseline vs CPS Stroke Subjects: Modafinil Stroke Subjects: Placebo Stroke Subjects Placebo vs Modafinil
Hide Arm/Group Description:

Normal subjects are persons without stroke who receive baseline and CPS conditions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients

Overall Number of Participants Analyzed 21 7 7 7 7
Mean (Standard Deviation)
Unit of Measure: seconds
.029  (.121) -.058  (.512) .48  (1.05) .12  (.11) .36  (1.06)
Time Frame 2 years
Adverse Event Reporting Description Adverse Events were recorded in a cumulative fashion for stroke participants, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
 
Arm/Group Title Normal Subjects Stroke Subjects
Hide Arm/Group Description

Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Follow up: Follow up testing occurred at 3 months

Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.

Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients

Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Baseline: Observations made at baseline before any intervention

CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.

Post CPS: 20 minutes following the CPS condition.

Follow up: Follow up testing occurred at 3 months

All-Cause Mortality
Normal Subjects Stroke Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Normal Subjects Stroke Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      2/7 (28.57%)    
Musculoskeletal and connective tissue disorders     
broken hip * [1]  0/21 (0.00%)  1/7 (14.29%) 
Vascular disorders     
stroke * [2]  0/21 (0.00%)  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
[1]
one participant broke a hip but this was not related to the study
[2]
One participant had an additional stroke that was unrelated to the study
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Subjects Stroke Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      6/7 (85.71%)    
Nervous system disorders     
headache * [1]  0/21 (0.00%)  0 2/7 (28.57%)  2
difficulty sleeping * [2]  0/21 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
rash * [3]  0/21 (0.00%)  0 3/7 (42.86%)  3
Vascular disorders     
vasovagal response * [4]  1/21 (4.76%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
headache with or without dizzyness
[2]
report of difficulty sleeping
[3]
rash with or without itchyness
[4]
One normal subject had a vasovagal response during the swallowing evaluation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Mennemeier, PhD
Organization: University of Arkansas for Medical Sciences
Phone: 501 526 7773
EMail: msmennemeier@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01085903    
Other Study ID Numbers: 110644
R21HD055677 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2010
First Posted: March 12, 2010
Results First Submitted: July 25, 2016
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016